MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749085263022

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: returned product consisted of an expo diagnostic catheter with a guidewire in the device and the device inside of an introducer sheath.The catheter shaft was checked for damage.Visual analysis showed a guidwire inside of the expo.The wire had punctured the shaft approximately 8cm from the tip.The entire device with the guidewire was inside an introducer sheath when returned.The guidewire was pulled out of the expo.The expo was then pulled from the introducer sheath.The damage was caused by the guidewire sticking through the shaft of the device.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 investigation completed on 25jul2018.It was reported that shaft damage occurred.The target lesion was located in the heart.A model-5f expo multipack 155 was selected for use.During diagnostic heart cath, the physician was advancing the j wire with the pigtail across the valve, however, the j wire went through the side hole on the pigtail catheter and it kinked the catheter.Thus, everything was removed and they went in with a new one and everything worked fine.And then afterwards, the physician felt that the expo catheters had a bigger angle than they used to have.The procedure was completed with another with the same device.No patient complications were reported and the patient is fine.However, device analysis revealed shaft hole/perforated.

• Brand Name: EXPO GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPORATED; 5950 nancy ridge drive; san diego CA 92121
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7786128
• MDR Text Key: 117269457
• Report Number: 2134265-2018-07285
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2020
• Device Model Number: H749085263022
• Device Catalogue Number: 08526-302
• Device Lot Number: 0060123556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2018
• 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