MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER AMPLATZ TYPE RENAL DILATOR/SHEATH SET; DILATOR, CATHETER, URETERAL

Model Number	M0062602500
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 an amplatz sheath dilator set was unpacked on (b)(6) 2017.According to the complainant, a foreign object was noted to be present inside the sterile package.They discontinued on using the device.The procedure was completed with another amplatz sheath dilator set.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported as "no consequences".
Additional Manufacturer Narrative
A visual examination of the returned amplatz sheath dilator set found that the device pouch was completely open.There was an evidence of the heat seal throughout the entire width of pouch without any breaks.No foreign matters were noticed inside the pouch and the sheath dilator set.Based on the condition of the returned device, the reported presence of foreign matter was not confirmed.The returned device showed no evidence of either the alleged issue or any other defect which could have contributed to the event (visual, physical and performance testing).Therefore the root cause for this complaint cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz sheath dilator set was unpacked on (b)(6) 2017.According to the complainant, a foreign object was noted to be present inside the sterile package.They discontinued on using the device.The procedure was completed with another amplatz sheath dilator set.There were no patient complications reported as a result of this event.The patient's condition after the procedure was reported as "no consequences".

• Brand Name: AMPLATZ TYPE RENAL DILATOR/SHEATH SET
• Common Device Name: DILATOR, CATHETER, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6910134
• Report Number: 3005099803-2017-02944
• Device Sequence Number: 13631343
• Product Code: EZN
• UDI-Device Identifier: 08714729137122
• UDI-Public: 08714729137122
• Combination Product (Y/N): N
• PMA/510(K) Number: K851144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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: 06/01/2021
• Device Model Number: M0062602500
• Device Catalogue Number: 260-250
• Device Lot Number: 20721776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1