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

Model Number H74908641222

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2018

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 analysis.Device analysis revealed that the catheter shaft was checked for damage.No damage was noticed on the catheter shaft.The tip showed a small hole approximately 3mm from the very end of the tip.The damage was caused by the guide wire sticking through the tip 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

It was reported that a hole in the tip occurred.The target lesion was located in the coronary artery.A 6f expo fl4 diagnostic guide catheter was selected for use.During the percutaneous coronary intervention (pci) while the physician was inserting a 0.035 non- bsc wire into the diagnostic catheter it was noted that there is a hole at the tip of the catheter so the wire came out at the tip of the diagnostic catheter.The procedure was completed with another with the same device.No patient complications were reported and the patient¿s status is stable.

• 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: 7426563
• MDR Text Key: 105335476
• Report Number: 2134265-2018-03133
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: K992142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: H74908641222
• Device Catalogue Number: 08641-22
• Device Lot Number: 0060034266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1