MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7; QEW

Model Number	CAT7XTORQ130KIT-A
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned cat7 confirmed that the catheter was fractured on the midshaft.Based on the damage at the fracture site, this fracture likely occurred when the catheter was torqued.The description of the event noted that the distal tip of the catheter was not responding when the physician attempted to torque the catheter, which may have been due to interaction with the stent.The returned device was also kinked at the distal tip which likely occurred when the catheter was advanced without a guide wire and may also be related to interaction with the stent.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure of an occluded stent in the superficial femoral artery (sfa) using an indigo system aspiration catheter 7 (cat7) and non-penumbra sheath.During the procedure, the tip of the cat7 kinked when advanced out of the sheath without a guidewire.It was reported that this may have been due to an interaction with the stent.An 0.035" guide wire was then advanced through the cat7 to straighten out the tip.The guidewire was then removed.The physician then torqued the cat7 one full rotation and noticed the distal tip was not responding.The catheter had fractured proximal to the vascular sheath valve, outside of the patient.Subsequently, the cat7 was removed.The procedure was completed using an indigo system aspiration catheter 8 (cat8) and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11337835
• Report Number: 3005168196-2021-00292
• Device Sequence Number: 19703909
• Product Code: QEW
• UDI-Device Identifier: 00815948021648
• UDI-Public: 00815948021648
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2021
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2023
• Device Model Number: CAT7XTORQ130KIT-A
• Device Catalogue Number: CAT7XTORQ130KIT
• Device Lot Number: F98338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005