MAUDE Adverse Event Report: CREAGH MEDICAL LTD. HP; PTA BALLON DILATATION CATHETER

Model Number	UHP75124
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Event or Problem Description
Account reports balloon broke off while in patient's venous system in shoulder.User facility could not see piece broken off and sent patient across street to iu methodist hospital ct to identify where piece was and treated patient as necessary.The balloon inflated the first time to full pressure; it burst at about 6-8 atmospheres on the second inflation.The facility believes the fractured piece was lodged in the stent that was placed.The facility was going to attempt to snare or clip the piece out.Same patient, same brachial cephalic stent graft but came in from the left side today through the ij and was in a different location on the stent - essentially the other end of the stent.Upon asking for further information it became evident that they stent has been implanted and came in to contact with the metal stent and the contact ruptured the balloon.

• Brand Name: HP
• Common Device Name: PTA BALLON DILATATION CATHETER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; ballinasloe, co. galway galway, H53 K 8P4; EI H53 K8P4
• MDR Report Key: 10148873
• Report Number: 3005994106-2020-00054
• Device Sequence Number: 3536138
• Product Code: LIT
• UDI-Device Identifier: 08570590020242
• UDI-Public: 08570590020242
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2022
• Device Model Number: UHP75124
• Device Catalogue Number: UHP75124
• Device Lot Number: 21904076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention