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

Model Number	M00547120
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was unpacked on (b)(6) 2019.According to the complainant, a black particle was noticed in between the product box and the plastic bag, and there was also a black particle in the sticky part of the seal.There was no damage noted to the device packaging, and the sterile seal did not appear to be compromised.There was no patient or procedure involved.
Additional Manufacturer Narrative
Problem code 2969 captures the reportable issue of foreign matter.According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was unpacked on (b)(6) 2019.According to the complainant, a black particle was noticed in between the product box and the plastic bag, and there was also a black particle in the sticky part of the seal.There was no damage noted to the device packaging, and the sterile seal did not appear to be compromised.There was no patient or procedure involved.Additional information received on 17apr2019: upon re-checking the product, it was noted that there was no black material found.

• Brand Name: EXTRACTOR PRO XL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8437611
• Report Number: 3005099803-2019-01291
• Device Sequence Number: 16701070
• Product Code: FGE
• UDI-Device Identifier: 08714729790648
• UDI-Public: 08714729790648
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102082
• 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,Followup
• Report Date (Section B): 05/14/2019

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: 10/09/2020
• Device Model Number: M00547120
• Device Catalogue Number: 4712
• Device Lot Number: 22772283
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/14/2019
• Patient Sequence Number: 1