MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00558710

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

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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.

Event Description

Note: this report pertains to one of two cre pro wireguided devices being unpacked at the same time.It was reported to boston scientific corporation that two cre pro wireguided dilatation balloon devices were delivered to the hospital and unpacked on (b)(6), 2019.According to the complainant, the sterile pouches of both devices were noted to be damaged.Photos sent by the customer shows indentations and/or small holes on both device pouches.This was found prior to use with a patient or procedure.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

Note: this report pertains to one of two cre pro wireguided devices being unpacked at the same time.It was reported to boston scientific corporation that two cre pro wireguided dilatation balloon devices were delivered to the hospital and unpacked on september 17, 2019.According to the complainant, the sterile pouches of both devices were noted to be damaged.Photos sent by the customer shows indentations and/or small holes on both device pouches.This was found prior to use with a patient or procedure.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

Problem code 2385 captures the reportable event of damage on the device pouch.Investigation result: a visual examination of the returned packaging found indentations located at the middle section of the pouch, right side near to the information label, in front of the pouch.No other issue was noted on the returned device.It is most likely that the manner the box was manipulated, transported and/or stored after it left the manufacturing process was not appropriate and resulted in the damages found; therefore the most probable root cause is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: CRE PRO
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9180024
• MDR Text Key: 173220737
• Report Number: 3005099803-2019-04947
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: 08714729797593
• Combination Product (y/n): N
• PMA/PMN Number: K112994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2022
• Device Model Number: M00558710
• Device Catalogue Number: 5871
• Device Lot Number: 0024241238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1