MAUDE Adverse Event Report: CONCENTRIC MEDICAL 9F BGC 80CM; CATHETER, PERCUTANEOUS

Catalog Number	90077
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is available, device analysis in progress.
Event or Problem Description
It was reported the balloon burst.There was no clinical consequence to the patient.
Additional Manufacturer Narrative
Expiration date - added.Device evaluated by mfg - updated.Summary attached - added.Manufacturing date - added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The device was returned and magnified inspection confirmed the balloon had a hole and noted the proximal shaft was damaged; no additional anomalies were observed.The balloon was unable to inflate and leaked during functional testing due to the damages noted.Because device analysis and the information available failed to identify an assignable cause, undeterminable was assigned to this event.
Event or Problem Description
It was reported the balloon burst.There was no clinical consequence to the patient.

• Brand Name: 9F BGC 80CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 7713219
• Report Number: 0002954917-2018-00062
• Device Sequence Number: 16410416
• Product Code: DQY
• UDI-Device Identifier: 00815742000771
• UDI-Public: 00815742000771
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 90077
• Device Lot Number: 0000003476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYNCHRO2 GUIDEWIRE (STRYKER)