MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE GUIDEZILLA¿ II PV LONG GUIDE EXTENSION CATHETER; CATHETER, PERCUTANEOUS

Model Number H74939395003506L0

Device Problems Physical Resistance (2578); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device was returned for evaluation.Returned product consisted of a guidezilla ii guide extension catheter.The tip, distal shaft, collar and hypotube was microscopically and tactile inspected.There is blood on and inside of the shaft.Inspection revealed a partial separation of the shaft at the collar.The damage seen is consistent with damage seen by use of advancing a catheter through the collar.There are numerous shaft kinks.The tip is damaged.During analysis the shaft became completely separated at the collar.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

Reportable based on device analysis completed on 08-may-2018.It was reported that an imaging catheter became stuck in the collar part of guidezilla and collar part of guidezilla became damaged.The 99% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.After an unknown guidewire was inserted, a guidezilla¿ ii pv long guide extension catheter was used to help advance an opticross¿ imaging catheter.However, during procedure, it was noted that the tip of the opticross¿ imaging catheter was caught in the collar part of the guidezilla¿ ii.The imaging catheter was then forcibly pushed; however, the imaging catheter was kinked and the collar part of the guide extension catheter became damaged.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed a partial separation of the shaft at the collar.

• Brand Name: GUIDEZILLA¿ II PV LONG GUIDE EXTENSION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7560337
• MDR Text Key: 109765834
• Report Number: 2134265-2018-04678
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2019
• Device Model Number: H74939395003506L0
• Device Lot Number: 21629073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMAGING CATHETER: OPTICROSS