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

Catalog Number	SEP8
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2017-00512, 3005168196-2017-00513.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right common femoral vein using indigo system separator 8 (sep8) and indigo system aspiration catheter 8 (cat8) devices.During the procedure, while in use with a cat8, the distal tip of the sep8 became lodged in the chronic, organized clot in the target vessel.While the sep8 was being retracted, the soft wire distal to the bulb stretched.The physician did not mention resistance but the sep8 tip could be seen buckling against the thrombus.The sep8 was removed and the physician continued the procedure using a new sep8.While removing the new sep8 after completing a pass, the bulb of the sep8 was pulled off the wire and remained within the rotating hemostasis valve (rhv).The physician did not mention resistance while removing the sep8.The cat8 was then removed to be flushed.While an angiogram was being performed, the nurse was looping the cat8 to store on the trolley and inadvertently kinked the cat8 at the mid-shaft.Therefore, the procedure was completed using a combination of direct aspiration as well as a selection of wires to agitate the thrombus through a new cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the indigo system separator 8''s (sep8) core wire was fractured approximately 150.0 cm from the proximal end of the sep8, just distal to the bulb.The bulb was intact with the sep8 delivery wire.The platinum wire was unraveled, but not fractured, and the distal atraumatic tip was hanging off the distal end of the sep8.Conclusions: evaluation of the first sep8 revealed that the core wire was fractured and the platinum wire was unraveled, but the bulb and distal atraumatic tip were not separated from the rest of the sep8.Fracture of the core wire may have occurred due to forceful advancement of the sep8 against a chronic, organized clot, and may allow the platinum wire to unravel.Evaluation of the second sep8 revealed that the core wire was fractured, the platinum wire was unraveled, and the bulb was separated from the rest of the sep8.This damage likely occurred due to retraction of the sep8 through a closed rotating hemostasis valve (rhv) valve.The distal atraumatic tips of both sep8''s were not separated from the rest of the sep8''s.The indigo system aspiration catheter 8 (cat8) mentioned in the complaint was not returned for evaluation.Penumbra separators and 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.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6449553
• Report Number: 3005168196-2017-00511
• Device Sequence Number: 658107
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2017

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: 08/30/2018
• Device Catalogue Number: SEP8
• Device Lot Number: F65540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR