MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 7F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	LA7MAC35
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis on the 7f launcher guide catheter: the catheter exhibited severe twisted sections 60cm and 68cm from the tip, the catheter appeared to have been turned more than 10 times.The catheter exhibited exposed braid wire in the two severely twisted areas noted on the catheter.Functional testing could not be performed due to the condition of the returned device.No other damage noted to the catheter.During measurements of the catheter, the inner and outer diameter of the shaft met specification and not a contributor to the event.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using a launcher guide catheter; the intended lesion was in the mid rca exhibiting moderate tortuosity, no other lesion details available.There was no damage to the (b)(4) packaging.The guide catheter was removed from packaging, inspected and prepped per ifu with no issues noted.Resistance was encountered when advancing the device across the lesion, excessive force was not applied.The guide catheter was exchanged with another launcher guide catheter.The resistance was not due to tortuosity.It is reported that on removal from the patient, the guide catheter was noted to be twisted.No injury was caused as a result of this event.Analysis of the returned device revealed an exposed braidwire.

• Brand Name: LAUNCHER 7F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6848219
• Report Number: 1220452-2017-00088
• Device Sequence Number: 13479920
• Product Code: DQY
• UDI-Device Identifier: 00613994831590
• UDI-Public: 00613994831590
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K022764
• 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
• Report Date (Section B): 08/10/2017

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: Health Professional
• Device Expiration Date: 09/12/2018
• Device Catalogue Number: LA7MAC35
• Device Lot Number: 0008216438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1