MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that a right lower extremity (rle) angiogram was performed, upon closing a regular 6 french sheath attempted removal resulted in a sheath breaking in half.The sheath separated in the middle; the part attached to hub was removed safely.Approximately 5cm of segment remained behind in the patient's common femoral artery.Physician accessed an 8 french pinnacle sheath on the contralateral side to snare out however it was unsuccessful.Patient was then transferred to a cath lab where an additional percutaneous procedure was performed and resulted in a successful removal.Patient was in stable condition.The event occurred post-treatment.There is a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information received 16 jun 2023: two separate sheaths were used on same procedure.Additional information received 22 jun 2023: there was not a difficult patient anatomy (resistance) experienced during removal that may have contributed to the broken sheath based on the angiogram.There was not any difficulty introducing the device for the procedure.The problem occurred after intervention was complete without issue.Removal of sheath was done in a surgical setting at a different location.The intervention involved in the percutaneous procedure for removal was an 8 french sheath accessed the right superficial femoral artery (sfa) and a 035 glidewire advanced up into the aorta.A snare was introduced alongside the wire and the capture of original sheath remnant was obtained successfully.The sheath and snare were removed, and closure was performed over a 035 glide to successfully complete the case.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device was not available for returned; therefore, an evaluation of the actual device will not be conducted.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.This report is for the first device reported, for the second device reported that was used on the same patient see mdr 1118880-2023-00350.
Event or Problem Description
Additional information was received on 01 aug 2023: the procedure was a left heart catheterization, so only wires and catheters were passed through the sheath.The patient did have some scarring around the access site from previous procedures.There was minimal resistance, however nothing that should have caused the sheath to separate the way it did.The body of the sheath seemed very thin and weak compared to other sheaths we have used previously.
Additional Manufacturer Narrative
This report is being sent as follow-up # 1 to provide additional information in section b5 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for sheath separation because the sample was not returned for assessment.Without a sample, the exact root cause could not be determined.It is possible the increased resistance due to scarring at the access site led to the sheath breakage.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• Common Device Name: 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17330414
• Report Number: 1118880-2023-00349
• Device Sequence Number: 6072929
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: 0000299740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8FR PINNACLE IK.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White