MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00568201
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was reported to the fda via a voluntary medwatch report.The report number is (b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy (peg) tube placement procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2019, the peg tube broke.The patient brought the peg tube to the hospital.The internal bolster was missing.Reportedly, the detached portion was not removed.A new peg tube was replaced (manufacturer unknown.) there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
E4: this event was reported to the fda via a voluntary medwatch report.The report number is (b)(4).H6 (device codes): problem code 2907 captures the reportable event of internal bolster detached.H10: a visual examination of the returned device had residue inside of the tube indicates signs of use.In addition, the bolster was detached.There appeared to be evidence of a proper bolster-tube bond, as seen in the residue on the distal end of the tube.The complaint was consistent with the reported event of internal bolster detached/separated.It is possible that several factors, such as wear and tear or patient use/handling, e.G.Excessive pulling on the peg tube, contributed to the reported complaint.Therefore, the complaint investigation conclusion code selected is cause traced to maintenance, which indicates that problems were traced to improper routine or preventative maintenance.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted device met all manufacturing specifications.A labeling review was performed, and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy (peg) tube placement procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2019, the peg tube broke.The patient brought the peg tube to the hospital.The internal bolster was missing.Reportedly, the detached portion was not removed.A new peg tube was replaced (manufacturer unknown.) there were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8365937
• Report Number: 3005099803-2019-00915
• Device Sequence Number: 11099251
• Product Code: KNT
• UDI-Device Identifier: 08714729285199
• UDI-Public: 08714729285199
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K031538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 05/31/2020
• Device Model Number: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 22202036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 03/03/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 84