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

Catalog Number	CATD
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: both of the returned catds were ovalized on their distal tips.The first catd evaluated was ovalized approximately 17.0 cm from the hub.The peelable sheath was returned on the catd and was kinked near its distal end approximately 47.0 cm from the hub.Conclusions: evaluation of the returned catds revealed ovalizations on their distal tips.If the peelable sheath provided by penumbra is not properly used during introduction of the catd into a parent device, damage such as an ovalization may occur.The first catd evaluated was kinked on its distal end where the peelable sheath had been seated.This further supports the improper use of the peelable sheath upon attempts to introduce the device into the parent sheath.Forcefully gripping or pinching the device while attempting to advance the catd into a parent device may have contributed to the observed ovalizations.Further evaluation revealed kinks on the catd midshafts.These were likely incidental and likely a result of the returned condition.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.This report is associated with mfr report number: 3005168196-2018-01332.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to de-clot a loop graft using indigo system catd aspiration catheters (catds).During the procedure, the tip of a catd became kinked while being advanced through a non-penumbra sheath and, therefore, the catd was removed.The physician then attempted to use a new catd, however, the tip of the new catd became kinked as well, and therefore, it was removed.The physician then noticed that the loop graft had torn and, therefore, the physician implanted stents to treat the tear.The patient was then sent to the operating room to remove the arterial plug and complete the procedure.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER D
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7660245
• Report Number: 3005168196-2018-01331
• Device Sequence Number: 14110832
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/08/2018

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: Physician
• Device Expiration Date: 02/14/2020
• Device Catalogue Number: CATD
• Device Lot Number: F74426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/03/2018
• 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
• Patient Age: 34 YR