MAUDE Adverse Event Report: MEDTRONIC, INC ZUMA ZM 5F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	ZM5JL30
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Patient Problem/Medical Problem (2688)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician was attempting to use a zuma guide catheter during an angioplasty procedure.No damage was noted to packaging.The device was removed from packaging per ifu with no issues noted.The device was inspected and prepped with no issues noted.No resistance was encountered when advancing the device, however it was reported that excessive force was used on delivery.It was reported that the tip of the zuma was damaged.The catheter was folded in the digital arteries at two locations.There was no excessive torquing.To remove the guide, cutting of the guide by scalpel was required.This was done without vascular damage.There was no detachment.The catheter remained folded.All of the zuma was successfully removed from the patient.The patient experienced pain associated with forced removal.The patient required analgesics.No hematoma reported.
Additional Manufacturer Narrative
Evaluation summary: the 5f catheter exhibited kinks 62.5cm, 57.5cm, 43cm, 43cm and 19cm from the distal hub.The catheter exhibited severe torsional kink at the distal cut end, with at least five turns.The catheter was cut by the user (as stated in the reported event) with a scalpel.The catheter full length received was 90cm.With the distal section missing and not returned.Since the distal portion of the catheter was not returned no further analysis can be conducted at this time.The actual length for this zuma catheter overall length is 100cm as stated in the label.Approximately 10cm of the catheter was not returned.The inner and outer diameter of the shaft meet specification.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.

• Brand Name: ZUMA ZM 5F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 6328339
• Report Number: 1220452-2017-00010
• Device Sequence Number: 13652799
• Product Code: DQY
• UDI-Device Identifier: 00613994817068
• UDI-Public: 00613994817068
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K990707
• 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): 03/28/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2018
• Device Model Number: ZM5JL30
• Device Catalogue Number: ZM5JL30
• Device Lot Number: 0008342120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2017
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention