MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P DESTINATION SLENDER GUIDING SHEATH; INTRODUCER, CATHETER

Model Number N/A

Device Problem Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer date - unknown due to unknown lot number.Device manufacturer date - unknown due to unknown lot number.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.\the production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported that the r2p destination sheath was used for a r2p case.The superficial femoral artery (sfa) was treated successfully with atherectomy, stenting and ballooning.Perforation of the sheath was identified at the end of the case as the sheath was being withdrawn for final angiography.The perforation was identified outside of the body.The dilator and wire were inserted, and sheath was removed without issue.The patient's condition was stable.The procedure outcome was successful.There was no patient injury, medical/surgical intervention required.

Manufacturer Narrative

This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.One 119 cm 6fr r2p destination sheath was received for product evaluation.Visual inspection of the sheath revealed a tear in the outer layer of the sheath at 14.35 cm from the sheath hub.The outer layer of the sheath at the tear was also found to be stretched.The sheath was viewed under microscope and the inner layer was stretched but not torn.The coiling at the tear was uniform and no deformations were noted in the coiling.The sheath was also flattened at 20.5 inches from the sheath hub.Kinks were noted at 47.5 cm, 114.3 cm, and 116.3 cm from the sheath hub.Based on the information provided, the exact root cause of the event cannot be determined.However, it is possible that mishandling of the device during removal of the sheath caused the damage noted on the sheath.It is likely that tensile and torsional forces gradually stretched the inner and outer layers of the sheath.It is also possible that during manipulation of the sheath, the d-wire inside the two layers sheared the outer layer during bending and kinking of the sheath.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: R2P DESTINATION SLENDER GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11277957
• MDR Text Key: 230258800
• Report Number: 1118880-2021-00005
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K193125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/04/2021; 03/22/2021
• Supplement Dates FDA Received: 02/25/2021; 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CSI ATHERECTOMY; METACROSS BALLOONS; MISAGO STENT; CSI ATHERECTOMY; METACROSS BALLOONS; MISAGO STENT
• Patient Age: 74 YR