MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 6 ASPIRATION CATHETER; DXE

Catalog Number CAT6

Device Problems Physical Resistance (2578); Material Deformation (2976); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2017

Event Type  malfunction  

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.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using indigo system aspiration catheters 6 (cat6s).During the procedure, after completing a pass using a cat6 with a non-penumbra sheath, the physician wanted to remove the cat6 to clean sheath rotating hemostasis valve (rhv) which was clogged; however, the rhv was too tight.Therefore, the physician used a hemostat to loosen the rhv.The physician then used another rhv at the hub of the sheath to minimize blood loss while cleaning sheath rhv.It was reported that the physician used the rhv on the hub of the cat6 but clamped the shaft of the sheath instead of the hub.Consequently, the sheath became ovalized.While attempting to re-insert the cat6 into the sheath using the sheath rhv, the physician met resistance at the damaged portion of the sheath which impacted the shape of the cat6.Therefore, the physician removed the cat6, and used the sheath inner dilator to run through the sheath and reshape it.The procedure was then completed using a new cat6 and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Pma/510(k) # was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report.

• Brand Name: INDIGO SYSTEM CAT 6 ASPIRATION CATHETER
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6989278
• MDR Text Key: 91196878
• Report Number: 3005168196-2017-01915
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

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
• Device Operator: Physician
• Device Expiration Date: 02/22/2020
• Device Catalogue Number: CAT6
• Device Lot Number: F74558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 10/05/2017
• Supplement Dates FDA Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 136