MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; BALLOON DILATOR

Model Number	M00558660
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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 or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was inspected on an unknown date.According to the complainant, during inspection of the stored products, it was noted that the packaging of the device was deteriorated and the sterile barrier was compromised.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.

• Brand Name: CRE PRO
• Common Device Name: BALLOON DILATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8688358
• Report Number: 3005099803-2019-02880
• Device Sequence Number: 11350274
• Product Code: FGE
• UDI-Device Identifier: 08714729797548
• UDI-Public: 08714729797548
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2021
• Device Model Number: M00558660
• Device Catalogue Number: 5866
• Device Lot Number: 0022490387
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1