MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUPER SHEATH INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	28193
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.A 7frx7cm super sheath introducer sheath was selected for use.During preparation, the device was selected knowing that there was no ro marker on this model even though the account normally uses sheaths that have ro markers.During the procedure, inside the patient, a complete crack/fracture along the length of the device occurred.It was possible that a balloon was inflated too soon relating to this.The device was removed and the procedure was completed another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the sheath and dilator were returned for analysis.Visual analysis revealed a crack on the sheath tip.There was no abnormality found on the dilator.Manufacturing records were reviewed and no record showed a compatibility issue that a dilator could not be inserted into a sheath in the assembling process.It was confirmed that the device met all material, assembly and performance specifications.Testing of dilator passage into sheath was also conducted in the manufacturing process for all the products and all passed the inspection without any issue.No other damages or irregularities were found.
Event or Problem Description
It was reported that the device was fractured.A 7frx7cm super sheath introducer sheath was selected for use.During preparation, the device was selected knowing that there was no ro marker on this model even though the account normally uses sheaths that have ro markers.During the procedure inside the patient, a complete crack/fracture along the length of the device occurred.It was possible that a balloon was inflated too soon relating to this.The device was removed and the procedure was completed another of the same device.No patient complications were reported.

• Brand Name: SUPER SHEATH INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8503864
• Report Number: 2134265-2019-03561
• Device Sequence Number: 1628879
• Product Code: DYB
• UDI-Device Identifier: 14543527197202
• UDI-Public: 14543527197202
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K060190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 06/30/2021
• Device Model Number: 28193
• Device Catalogue Number: 28193
• Device Lot Number: 18G19B8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Received by Manufacturer: 03/17/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1