MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7132
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination occurred.Upon opening a 2.50mm x 12mm emerge balloon catheter, the balloon pocket was found to be damaged, and the product was contaminated.The device was not used, and the procedure was completed with another of the same device.
Event or Problem Description
It was reported that contamination occurred.Upon opening a 2.50mm x 12mm emerge balloon catheter, the balloon pocket was found to be damaged, and the product was contaminated.The device was not used, and the procedure was completed with another of the same device.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter, its outer box packaging, inner tyvek packaging with shipping hoop and balloon protector.The outer box, closure strip, and product pouch were visually examined.Inspection of the outer box revealed that the top edge of the box was damaged indicative to handling while opening product.The top closure strip was secure which includes product label placement which was not compromised, unsealed, or broken.The bottom closure strip was unsealed.Inner tyvek packaging was removed for visual examination.The tyvek seal was visually inspected.The bottom tyvek (white) seal was pulled and curled up on the back flap of the packaging far enough that the device was elementally exposed.However, all seals on the package were complete and sealed at one point without error.With no further damage or irregularity to the packaging present, the shipping hoop was removed and examined.With no damage present, the device was removed from the hoop for analysis.The device was visually and microscopically examined.The balloon protector, with no damage, was present and was removed without issue.There were no fluids within the device, and no visible damage.The balloon was tightly folded indicating that the device was not inflated.Photo media reviewed depicted outer box packaging to the reported device, however, no damage was detected.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15726426
• Report Number: 2124215-2022-43780
• Device Sequence Number: 11481213
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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: 11/10/2024
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0029057997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 73 KG