MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Hematoma (1884); No Code Available (3191)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, non conformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, distal embolization, kidney damage from contrast media, hematoma or hemorrhage at access site, including death.Therefore, it was determined that the reported adverse events were anticipated complications.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.(b)(4).This report is associated with mfr report number: 3005168196-2020-01167.

Event Description

Penumbra inc.Became aware on 15-jul-2020 during its post-market surveillance activities of a journal article titled, "single-center experience with indigo aspiration thrombectomy for acute lower limb ischemia." (lopez et al., 2020).It was reported that 41 patients underwent 43 thrombectomy procedures involving indigo system aspiration catheter 3 (cat3) and indigo system aspiration catheter 5 (cat5).All data were collected from a single-center retrospective review between 2014 and 2017.Among all patients, five experienced adverse events including: intraoperative distal embolization, acute kidney injury, spontaneous calf hematoma, large hematoma, and compartment syndrome.There is no allegation within the article that a malfunction of the indigo system occurred.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints.Therefore, this report addresses all adverse events within this literature.

• Brand Name: INDIGO SYSTEM CAT3 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: 10394178
• MDR Text Key: 202532951
• Report Number: 3005168196-2020-01166
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/15/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other