MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK CRE¿ FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number M00558370

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was unpacked on an unknown date.According to the complainant, it was noted that there was a cut in the sterile package.It was noted that the outer shipping box was intact.

Manufacturer Narrative

A visual examination of the returned complaint device revealed a cut in the information label of the device.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during shipping, unpacking or preparation of the device for the procedure.Therefore, the most probable root cause of this complaint is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a cre fixed wire dilatation balloon was unpacked on an unknown date.According to the complainant, it was noted that there was a cut in the sterile package.It was noted that the outer shipping box was intact.

• Brand Name: CRE¿ FIXED WIRE
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6813538
• MDR Text Key: 83533154
• Report Number: 3005099803-2017-02572
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

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: 06/16/2019
• Device Model Number: M00558370
• Device Catalogue Number: 5837
• Device Lot Number: 20777763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2017
• 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