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

Catalog Number	CATD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the catd was fractured at the hub underneath the id band.The catd was kinked approximately 36.0, 48.0, and 50.0 cm from the hub.The inner catheter lumen displayed torqueing and twisting damage.Conclusions: evaluation of the returned catd revealed a fracture under the id band at the hub of the device.This damage was likely a result of excessive torqueing while making several passes during the procedure.The fraying of the catheter and liner observed at the fracture site combined with the lack of yielding suggest this torqueing failure.Further evaluation revealed kinks on the distal end of the device.These kinks were likely incidental and may have occurred during packaging for return to penumbra.The 8f short sheath mentioned in the complaint was 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 a thrombectomy procedure in the left subclavian vein using an indigo system aspiration catheter d (catd).During the procedure, the physician placed an 8f short non-penumbra sheath into the left brachial vein, then inserted a catd into the sheath.The physician then made five to six passes with the catd pulling negative with a 60 cc syringe.It was reported that after each pass, the physician pulled the catd out under manual aspiration then flushed the syringe and catd on the back scrub table.On the seventh or eighth insertion of the catd, the physician pulled negative with the 60 cc syringe and started to withdraw the catd; however, the distal end of the catd separated from the catheter.It was reported that the catd separated at the junction where the white hub part of the catheter meets the green part of the catheter about 30 cm from the proximal tip of the catd.The physician reinserted the tip back onto the green portion of the main catd and withdrew the entire catd from the body.The physician then tested the catd on the back scrub table, flushing the catd and pulling negative with a 60 cc syringe and decided the catd was in working order.The catd was then reinserted into the patient¿s body and the procedure was completed after performing two additional passes with the same catd and sheath.It was also reported that the physician never hooked up the indigo aspiration tubing or the penumbra system aspiration pump max 110v (pump max).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2017-02156.1.510(k): additional 510(k)# that also applies to this complaint: k160533, k161523.

• 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: 7088979
• Report Number: 3005168196-2017-02156
• Device Sequence Number: 16423737
• Product Code: DXE
• UDI-Device Identifier: 00814548017624
• UDI-Public: 00814548017624
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017
• 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: Physician
• Device Expiration Date: 02/22/2020
• Device Catalogue Number: CATD
• Device Lot Number: F74552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005