MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned to the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code has been referenced in the conclusions.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.

Event Description

The user facility reported that a 6f green terumo sheath was returned with a medtronic self-expanding stent system.The sheath was cut by the physician once resistance was experienced attempting to withdraw the deployment system catheter.It is possible damage encountered to the sheath during the course of the procedure contributed to the withdrawal difficulties.Additional information was received on 1/2/2018: complaint issue: as reported description: the patient had a previous pta in the right common iliac artery, during a follow-up check the angiogram showed a small dissection in the right common iliac artery.The physician intended to use the protégé everflex to treat the dissection in the common iliac artery as per ifu.It was reported the vessel was pre-dilated, using a 0.035 wire the physician attempted to advance the device through a 6fr sheath.The device became stuck in the sheath, a second attempt was made to advance the device unsuccessfully.The 0.035 wire was changed for another 0.035 wire, the same advancement issues remained.The physician pulled back the delivery system and observed a break in the shaft, the stent was not mounted on it.The physician pulled back the sheath, cutting it with a knife, revealing the stent inside the sheath.The decision was made not to stent the patient as the blood flow was good.No injury to the patient reported.Additional information was received on 1/2/2018: medtronic investigative conclusion: the reported event of difficulty experienced while attempting to retrieve the everflex catheter has been confirmed; however, the report of the stent remaining in the sheath was not confirmed.The everflex device was returned with the stent loaded within the catheter.A bend/twist to the catheter shaft was identified approximately 15cm from the distal tip.The returned sheath showed a cut approximately 10.5cm from the sheath distal tip.The sheath remained as one unit, being held together by the internal metal coil.The exposed portion of the coil was stretched out.There was no sign of a stent located within the lumen of the sheath.It should be noted a bend to the sheath was observed proximal location of the cut.The probable root cause of the inability to load and retrieve the evercross catheter was due ancillary device interaction.Damage to returned everflex was likely the result of attempting to pull and possibly twist the catheter against resistance.The everflex was able to be loaded within a 6f sheath from the lab with no resistance.A bend observed proximal to the cut on the sheath may have contributed to the reported difficulties.It is possible if the sheath was bent while attempting to load and/or retrieve at catheter, resistance would be encountered due to the restricted luminal clearance.Contributing factors associated to vessel anatomy, ancillary device interaction, and loading/retrieval technique could not be evaluated in this investigation.

Manufacturer Narrative

One used 6fr destination device was returned for evaluation.The device was decontaminated per terumo medical corporation's policies and procedures.No accessory components were returned with the device.After decontamination, the sheath was subjected to visual analysis.Blood like substance was observed on the device.The sheath was returned with a crosscut valve properly secured to the sheath hub.No anomalies were noted with the 3wsc or side tubing.There was a break in the sheath approximately 4.18" from the distal tip as measured with a sliding gauge.Around 15" of the metal coiling was exposed.The exposed metal coiling linked the two segments of the sheath.Microscopy was used to examine the sheath.There was deformation at the distal tip of the sheath.At the fracture site of the sheath, a fragment appeared partially detached.The remaining section of the fracture site was blunt.The complaint could be confirmed for sheath damage as the sheath was returned unraveled.There was only one fracture point along the sheath.The edges of the fracture site were blunt which indicates that they were caused by a sharp edge.From the complaint description, the physician did internationally cut the sheath.Additional damage was noted at the distal sheath tip where deformation was observed.The cause of the deformation is likely due to the atraumatic tip being exposed to a hard surface.The cause of the initial resistance cannot be determined.Aside from the distal tip deformation and intentional sheath cut, no other anomalies were noted with the sheath.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.

Manufacturer Narrative

This report is being submitted as follow up no.2 to correct the evaluation verbiage that was provided in the follow up no.1 report, correct the conclusion code to state that this report was determined not fda reportable.The evaluation in the follow up 1 reported was stated as "one used 6fr destination device was returned for evaluation.The device was decontaminated per terumo medical corporation's policies and procedures.No accessory components were returned with the device.After decontamination, the sheath was subjected to visual analysis.Blood like substance was observed on the device.The sheath was returned with a crosscut valve properly secured to the sheath hub.No anomalies were noted with the 3wsc or side tubing.There was a break in the sheath approximately 4.18" from the distal tip as measured with a sliding gauge.Around 15" of the metal coiling was exposed.The exposed metal coiling linked the two segments of the sheath.Microscopy was used to examine the sheath.There was deformation at the distal tip of the sheath.At the fracture site of the sheath, a fragment appeared partially detached.The remaining section of the fracture site was blunt.The complaint could be confirmed for sheath damage as the sheath was returned unraveled.There was only one fracture point along the sheath.The edges of the fracture site were blunt which indicates that they were caused by a sharp edge.From the complaint description, the physician did internationally cut the sheath.Additional damage was noted at the distal sheath tip where deformation was observed.The cause of the deformation is likely due to the atraumatic tip being exposed to a hard surface.The cause of the initial resistance cannot be determined.Aside from the distal tip deformation and intentional sheath cut, no other anomalies were noted with the sheath.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information." the correct evaluation verbiage is " one used 6fr destination device was returned for evaluation.The device was decontaminated per terumo medical corporation's policies and procedures.No accessory components were returned with the device.After decontamination, the sheath was subjected to visual analysis.Blood like substance was observed on the device.The sheath was returned with a crosscut valve properly secured to the sheath hub.No anomalies were noted with the 3wsc or side tubing.There was a break in the sheath approximately 4.18" from the distal tip as measured with a sliding gauge.Around 15" of the metal coiling was exposed.The exposed metal coiling linked the two segments of the sheath.Microscopy was used to examine the sheath.There was deformation at the distal tip of the sheath.At the fracture site of the sheath, a fragment appeared partially detached.The remaining section of the fracture site was blunt.The complaint could be confirmed for sheath damage as the sheath was returned unraveled.There was only one fracture point along the sheath.The edges of the fracture site were blunt which indicates that they were caused by a sharp edge.From the complaint description, the physician did intentionally cut the sheath.Additional damage was noted at the distal sheath tip where deformation was observed.The cause of the deformation is likely due to the atraumatic tip being exposed to a hard surface.The cause of the initial resistance cannot be determined.Aside from the distal tip deformation and intentional sheath cut, no other anomalies were noted with the sheath.There is no evidence that this event was related to a device defect or malfunction.".

• Brand Name: PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: terry callahan ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7205432
• MDR Text Key: 98058700
• Report Number: 1118880-2017-00101
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR