MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MACH1 GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number H74934356020

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that a foreign material found in the shaft.The target lesion is located in the right coronary artery (rca).During a percutaneous coronary intervention (pci), a mach1 guide catheter was selected.However, when the device was unpacked, the physician noticed two white spots, similar to a powder, at the center of the guide catheter's shaft.The procedure was completed with a different device.No patient complications were reported and the patient's status is good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for evaluation.Microscopic and tactile inspection revealed a kink 10cm from the tip of the device.No fm was found on the shaft or in the pouch.The device arrived in inside the pouch, without the cardboard backing.Inspection of the remainder of the device presented no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that a foreign material found in the shaft.The target lesion is located in the right coronary artery (rca).During a percutaneous coronary intervention (pci), a mach1 guide catheter was selected.However, when the device was unpacked, the physician noticed two white spots, similar to a powder, at the center of the guide catheter's shaft.The procedure was completed with a different device.No patient complications were reported and the patient's status is good.

• Brand Name: MACH1 GUIDE CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4994490
• MDR Text Key: 22647870
• Report Number: 2134265-2015-05165
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K020028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Report Date: 07/15/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: H74934356020
• Device Catalogue Number: 34356-02
• Device Lot Number: 0050678856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2012
• 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