MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Model Number	CAT8TORQ85KIT-A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 in the left superficial femoral artery (sfa) and iliac artery using an indigo system aspiration catheter 8 (cat8) and non-penumbra sheath.It was reported that the patient had a stent placed in the left iliac artery.During the procedure, the physician advanced the cat8 into the sfa and torqued the cat8 several times to aspirate the clot.It was also reported that the physician experienced resistance while torqueing the cat8 in one direction and experienced resistance while torqueing back the other direction.Subsequently, the cat8 became fractured and approximately 12 centimeters of the cat8 distal tip broke off.Therefore, the physician used a snare device to remove the fractured piece of the cat8.The procedure was completed using a new cat8 and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10146150
• Report Number: 3005168196-2020-00761
• Device Sequence Number: 2438463
• Product Code: DXE
• UDI-Device Identifier: 00815948020412
• UDI-Public: 00815948020412
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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): 05/19/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2021
• Device Model Number: CAT8TORQ85KIT-A
• Device Catalogue Number: CAT8TORQ85KIT
• Device Lot Number: C11285
• Was Device Available for Evaluation?: No
• 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: 05/19/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005