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

Catalog Number	CATRXKIT160
Medical Device Problem Codes	Sticking (1597); Physical Resistance (2578); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat rx was kinked in multiple locations along its length.The distal end of the cat rx was deformed, beginning approximately 154.0 cm from the hub.The guidewire lumen was torn.Dried blood was observed in the catheter lumen and guidewire lumen.Evaluation of the returned device revealed the guidewire lumen was torn.If blood begins to coagulate within the guidewire lumen, the guidewire may become stuck.If the guidewire is forcefully manipulated while it is stuck due to dried blood, tearing of the guidewire lumen may occur.Further evaluation revealed the cat rx was kinked in multiple locations along its length and deformed near its distal end.This damage may have occurred due to forceful manipulation of the cat rx during positioning within patient anatomy.The non-penumbra sheath and non-penumbra wire mentioned in the complaint were not returned for evaluation.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 thrombectomy procedure using an indigo system cat rx kit (kit).During the procedure, the physician completed two passes in the peroneal artery using an indigo system cat rx aspiration catheter (cat rx) with a non-penumbra destination sheath and a non-penumbra wire.It was reported that the cat rx was flushed after each pass.While advancing the cat rx to the target vessel for the third pass under aspiration, the physician experienced resistance.It was also reported that there was constant blood flow but the clot was never engaged; therefore, the physician decided to remove the cat rx.However, while removing the cat rx, the cat rx began sticking on the wire and the physician experienced resistance; therefore, the physician pulled the cat rx with the wire all together.It was also reported that the cat rx port was bending like an accordion when removing it over the wire outside the patient¿s body.The procedure was completed using percutaneous transluminal angioplasty (pta) once.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT RX ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6764522
• Report Number: 3005168196-2017-01338
• Device Sequence Number: 13956714
• Product Code: DXE
• UDI-Device Identifier: 00814548017587
• UDI-Public: 00814548017587
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: TZ
• PMA/510(K) Number: K163618
• 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): 07/12/2017

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: Physician
• Device Expiration Date: 03/15/2020
• Device Catalogue Number: CATRXKIT160
• Device Lot Number: C01117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR