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

Model Number H74908641022

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the inner device pouch was torn.During the preparation for a percutaneous transluminal coronary angioplasty procedure, it was noted that the bottom of the inner device pouch of an 6f expo guide catheter was torn.The procedure was completed with another of the same device.No patient complications and the patient's status is stable.

Manufacturer Narrative

Device evaluation by mfr.: device analysis determined that the condition of the returned packaging was consistent with the complaint incident.The reported damaged packaging was seen.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 most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that the inner device pouch was torn.During the preparation for a percutaneous transluminal coronary angioplasty procedure, it was noted that the bottom of the inner device pouch of an 6f expo guide catheter was torn.The procedure was completed with another of the same device.No patient complications 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5427553
• MDR Text Key: 37981569
• Report Number: 2134265-2016-00416
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 01/13/2016

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: 07/31/2017
• Device Model Number: H74908641022
• Device Catalogue Number: 08641-02
• Device Lot Number: 0050917492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2015
• 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
• Patient Age: 66 YR
• Patient Weight: 70