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

Catalog Number	LA7JL35SH
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 7f launcher guide catheter was intended to be used to treat a severely tortuous, moderately calcified lesion in the distal lad.There was no damage noted to the device packaging.The device was removed from the packaging with no issues.The device was inspected with issues.It is reported that the mid-section catheter became badly damaged and kinked while in the patient.Resistance was encountered when advancing the device and excessive force was used during insertion.The device was excessively torqued.The launcher was removed from the patient without intervention and was replaced with another launcher when implanting a stent.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis summary: as received the catheter was severely torqued, exhibiting approximately 8 turns.The catheter has exposed braids on the damaged area.The torqued section extends for approximately 4.5cmin length.The damage is 66cm from the tip.One torsional kink was noted 56.5cm from the tip.The tip of the catheter was round and smooth.Actual inner and outer diameter measurements met specifications.The catheter was torqued for approximately 8 turns.Image analysis: photo received matched the product returned, exhibiting torqued catheter shaft.If information is provided in the future, a supplemental report will be issued.

• 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: 7633266
• Report Number: 1220452-2018-00079
• Device Sequence Number: 16526272
• Product Code: DQY
• UDI-Device Identifier: 00613994832054
• UDI-Public: 00613994832054
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 09/21/2018

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: 03/29/2019
• Device Catalogue Number: LA7JL35SH
• Device Lot Number: 0008557771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 90