MAUDE Adverse Event Report: MEDTRONIC, INC ZUMA Z2 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	Z26FR40
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 zuma guide catheter was used during a procedure, femoral approach was used.The intended lesion was in the lad and was very tortuous.No damage was noted to the device packaging.The device was removed from packaging per ifu.The device was inspected and prepped prior to use.A large 45 cm sheath was also used.Resistance was encountered advancing the zuma, it could not reach the target lesion.Approximately a half to one third of the zuma broke off in the sheath prior to the attempted balloon delivery.The physician was able to remove the guide with the sheath with no harm to the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: received for analysis was a (b)(4) 6f zuma guide catheter with original folded pouch and die card, the outer box was not returned.The lot number 0009135539 matched the complaint file.The catheter was received in three pieces, the whole catheter was received.Approximate whole length received 108cm 60cm-120cm +1cm, -3cm or as requested by customer.Catheter actual inner diameter 0.070¿ and actual outer diameter 0.0815¿.Physical measurements show the device meets specification.Visual inspection detected a kink 14cm to the tip, the catheter exhibited crushed sections near the likely cut and torqued to break shaft.The twisting to the shaft was severe enough to close the inner lumen of the catheter at both ends of the break.The distal tip was found to be round and smooth and exhibited no damage.The introducer sheath was not returned to aid in definite root cause determination.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A zuma guide catheter was used during a procedure, femoral approach was used.The intended lesion was in the lad and was very tortuous.No damage was noted to the device packaging.The device was removed from packaging per ifu.The device was inspected and prepped prior to use.A large 45cm sheath was also used.Resistance was encountered advancing the zuma, it could not reach the target lesion.Approximately ½ to 1/3 of the zuma broke off in the sheath prior to attempted balloon delivery.The physician was able to remove the guide with the sheath with no harm to the patient.

• Brand Name: ZUMA Z2 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7669712
• Report Number: 1220452-2018-00088
• Device Sequence Number: 805226
• Product Code: DQY
• UDI-Device Identifier: 00613994813602
• UDI-Public: 00613994813602
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K010579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2018

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: 05/08/2020
• Device Catalogue Number: Z26FR40
• Device Lot Number: 0009135539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 11/07/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 71